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A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
NCT07230106 · Jiangsu HengRui Medicine Co., Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer
About this study
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
Eligibility criteria
Inclusion Criteria:
1. Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
2. Aged 18 to 80 years (inclusive), male.
3. ECOG performance status of 0 or 1.
4. Expected survival time ≥12 weeks.
5. Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
6. Able to provide sufficient tumor tissue samples for retrospective genetic testing.
7. Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
8. PSA level ≥1 ng/ml at screening.
9. Adequate organ function levels at baseline assessment.
10. Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.
Exclusion Criteria:
1. Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.
2. Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
3. Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
4. Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
5. Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
6. Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
7. Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
8. Poorly controlled tumor-related pain.
9. Dysphagia or other conditions significantly affecting drug absorption.
10. Known central nervous system metastases or primary brain tumors.
11. Significant pericardial, pleural, or peritoneal effusion requiring intervention.
12. Severe cardiovascular or cerebrovascular diseases.
13. Moderate to severe pulmonary disease significantly affecting respiratory function.
14. Poorly controlled diabetes.
15. Serious active infections within 14 days prior to enrollment.
16. Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
17. History of other malignancies within 5 years prior to enrollment.
18. Any other condition deemed by the investigator to potentially affect the study.
Study design
Enrollment target: 218 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-08
Estimated completion: 2029-12
Last updated: 2026-03-03
Interventions
Drug: HS-20093 for InjectionDrug: SHR3680 TabletDrug: Abiraterone TabletDrug: SHR2554 TabletDrug: Enzalutamide TabletDrug: Darotamine Capsule
Primary outcomes
- • Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate. (6 months.)
- • Cohort 2: Prostate Specific Antigen (PSA) response rate. (About 2 years.)
- • Cohort 2: Adverse events (AEs). (About 2 years.)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · industry
Contacts & investigators
ContactWenliang Wang · contact · wenliang.wang@hengrui.com · +86-0518-82342973
ContactQi Zhang · contact · qi.zhang@hengrui.com · +86-021-60453139
All locations (2)
Nanjing Drum Tower HospitalRecruiting
Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, Tianjin Municipality, China